Faster Time to Market (FTM)

The use of PAT is not limited to existing processes and products but is especially attractive in the scale-up and R&D of new processes and products. PAT is especially effective in scale-up. As PAT involves consideration of all monitored variables and not only an empirical selection of some of those variables, and since in-process monitoring techniques are normally multi-parametric (e.g. near infrared spectra of a whole sample), they will be more suited to capture scale effects present in the sample’s matrix that show up clearly in a consolidated multivariate analysis of quality and operating variables, thus helping the skilful engineer or scientist to pinpoint and solve scale-up problems thus resulting in a much faster process prototyping and scale-up.

We have several years of experience of scale-down and scale-up of chemical, pharmaceutical and biomanufacturing processes, directed towards rapid prototyping of processes. We have proven our approach in non-ideal chemical reactions and bio/pharmaceutical manufacturing both fermentation (USP), downstream (DSP), solid dosage formulation (SDF).

At 4Tune Engineering we can team up with your Process Development Team and shorten your time-to-market while at the same time achieving better quality, more robust and consistent processes.

Any sufficiently advanced technology is indistinguishable from magic.”

Arthur C. Clarke